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Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study

Denmark5 participantsStarted 2020-04-01

Plain-language summary

This project will determine the feasibility and validity of measuring elbow muscle flexor stiffness in a population of patients with sub-acute severe acquired brain injury using two measurement methods, the portable spasticity assessment device (PSAD) (Movotec, Charlottenlund, Denmark) and an ultrasound measurement called shear wave sonoelastography (SWE).

Who can participate

Age range5 Years – 99 Years

SexALL

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Inclusion criteria

✓. Fulfil the normal clinical requirements for treatment with BTX-A in at least one of their elbow flexors, (have increased stiffness in at least one of their elbow flexors, MAS greater than 0),
✓. Have given the normal informed consent to routine clinical treatment with BTX-A,
✓. Have given written informed consent or that proxy consent has been obtained, to participate in the study

Exclusion criteria

✕. Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements
✕. Cannot be positioned safely or comfortably for the measurements.

What they're measuring

Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD)

Timeframe: Twice at baseline and 4 weeks post BoNT-A injection

Change in muscle stiffness in the treated muscle(s) measured using the shear wave elastography (SWE)

Timeframe: Twice at baseline and 4 weeks post BoNT-A injection

Trial details

NCT IDNCT04207632

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-15

Contact for this trial

Derek J Curtis, phd

004538626683 derek.john.curtis@regionh.dk

View on ClinicalTrials.gov More Treatment Outcome trials